Intravesical Aminophylline to Facilitate Semi-Rigid Ureteroscopic Access in Children With Lower Ureteral Stones: A Prospective Randomized Double-Blind Placebo-Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study will evaluate whether intravesical aminophylline can facilitate semi-rigid ureteroscopic access in children with distal ureteral stones when the first gentle attempt to enter the ureter is unsuccessful.
Children scheduled for semi-rigid ureteroscopy for distal ureteral stones will first undergo the standard gentle attempt to pass the ureteroscope through the ureteric orifice and intramural ureter. If access is achieved, the child will continue standard treatment and will not be randomized. If access is not achieved, the child will be randomized during the operation to receive either intravesical aminophylline or intravesical normal saline placebo.
The study solution will be instilled into the bladder for approximately 5 minutes, then drained, and a second gentle ureteroscopic access attempt will be made. The main outcome is successful same-session passage of the intended semi-rigid ureteroscope without balloon dilation. The study will also assess the need for JJ stenting and deferred ureteroscopy, same-session stone treatment, operative outcomes, complications, and early aminophylline-related safety.
详细描述
This is a single-center, prospective, randomized, double-blind, placebo-controlled trial conducted at the Urology Department, Beni-Suef University Hospital.
The study population will include children with symptomatic distal ureteral stones who are scheduled for definitive treatment by semi-rigid ureteroscopy. All eligible children will undergo standard preoperative evaluation, including history taking, clinical examination, laboratory investigations, urine culture, imaging assessment, and anesthetic assessment.
During surgery, after cystoscopy and guidewire placement when feasible, the surgeon will make one standardized gentle attempt to pass a small semi-rigid ureteroscope through the ureteric orifice and intramural ureter. No forceful advancement, balloon dilation, ureteric orifice incision, or repeated traumatic manipulation will be allowed during this initial attempt. Children in whom the ureteroscope passes successfully will continue standard ureteroscopic treatment and will be recorded in a screening log but will not be randomized.
Only children with failed initial gentle negotiation will be randomized intraoperatively in a 1:1 ratio to one of two groups. The aminophylline group will receive intravesical aminophylline at a dose of 0.5 mg/kg diluted in 0.9% normal saline to a fixed total volume of 50 mL. The placebo group will receive 50 mL of 0.9% normal saline. The solution will be instilled through a urethral catheter, the catheter will be clamped for approximately 5 minutes, the bladder will then be drained, and a second gentle ureteroscopic access attempt will be made.
The surgeon, anesthetist, patient, family, and postoperative outcome assessor will remain blinded to treatment allocation. The study solution will be prepared by a clinician or pharmacist who is not involved in surgery or postoperative assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study solution will be prepared by a clinician or pharmacist not involved in surgery or postoperative assessment. The surgeon/investigator, anesthetist/care provider, participant and family, and postoperative outcomes assessor will remain blinded to treatment allocation.
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children older than 2 years and younger than 18 years.
- •Single unilateral lower/distal ureteral stone confirmed by low-dose non-contrast computed tomography according to local policy.
- •Stone size 5 to 15 mm.
- •Candidate for definitive treatment by semi-rigid ureteroscopy.
- •Sterile urine culture before surgery, or previously positive urine culture that has been properly treated before intervention.
- •Intraoperative failed initial gentle negotiation of the ureteric orifice/intramural ureter according to the study definition.
- •Written informed consent from the parent or legal guardian, with child assent when appropriate.
排除标准
- •Known hypersensitivity to aminophylline, theophylline, or ethylenediamine.
- •Use of oral or intravenous aminophylline or theophylline within the previous 24 hours.
- •Pre-existing ipsilateral JJ ureteral stent.
- •Stone peeping at the ureteric orifice.
- •Congenital or acquired abnormality that may affect distal ureteric access, such as ureterocele, obstructive megaureter, distal ureteric stricture, previous ureteric reimplantation, or previous ipsilateral ureteral reconstruction.
- •Known bladder dysfunction or conditions likely to affect normal bladder capacity.
- •Multiple ipsilateral ureteral stones or associated renal stones requiring flexible ureteroscopy or a ureteral access sheath strategy.
- •Febrile urinary tract infection, pyonephrosis, sepsis, or any case requiring urgent decompression instead of definitive ureteroscopy.
- •Cardiac disease, arrhythmia, uncontrolled hypertension, hyperthyroidism, epilepsy or seizure disorder, or significant hepatic impairment.
- •Inability to complete follow-up.
研究者
Hany Fathy Badawy, MD
Lecturer of Urology, Faculty of Medicine, Beni-Suef University
Beni-Suef University